BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 19840172 · Received July 26, 2024

    Report

    Report Number
    2029046-2024-02508
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000365 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A VIZIGO SHEATH AND A HEMOSTATIC VALVE LEAK ISSUE OCCURRED. VALVE OF THE VIZIGO SHEATH WAS REPORTED AS LEAKY FROM THE PHYSICIAN. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE SECTION WHERE THE ISSUE WAS OBSERVED WAS THE HEMOSTATIC VALVE AND IT WAS LEAKING. NOT SURE IF THE HEMOSTATIC VALVE DISLODGED INSIDE THE HUB. THE HEMOSTATIC VALVE DID NOT DISLODGE OUTSIDE OF THE HUB. THE BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS NOT USED ON THE PATIENT. ISSUE WAS NOTED PRE-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735060 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000365 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown